Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
In this study, smokers will be randomly assigned to one of three conditions for six weeks: 1)
nicotine-free cigarettes (0.05mg); 2) extra low nicotine cigarettes (0.3 mg); or 3) medicinal
4 mg nicotine lozenge. The tobacco toxin profiles across these various products will be
compared. The effects of these products on biomarkers of exposure and risk factors for
disease, compensatory smoking, components of tobacco addiction and short-term smoking
cessation will be determined. Predictors of response to these products (e.g., compensatory
smoking, compliance with product use, time to lapse) will also be examined.
The following primary hypothesis will be tested: 1) Extent of tobacco toxin exposure will be
greatest for the extra low nicotine cigarette and least for nicotine lozenge. Other secondary
hypotheses include: 2) Compensatory smoking, as calculated by using cotinine, will be
greatest for the extra low cigarette compared to the nicotine-free cigarette; 3) Greater
positive subjective responses to cigarettes will be observed with extra low nicotine vs.
nicotine-free cigarette; 4) Similar withdrawal symptoms and negative affect will be observed
with nicotine-free cigarette and nicotine lozenge, and least withdrawal and negative affect
with the extra low nicotine cigarette; 6) Least dependence and greatest motivation and
self-efficacy to quit will be observed with nicotine lozenge and the greatest dependence and
least motivation and self-efficacy to quit with the extra low nicotine cigarette use; 7)
Shorter time to lapse will be observed with extra low nicotine vs. nicotine-free cigarettes
because of extinction is likely to occur with nicotine-free cigarettes, and the longest time
to lapse for nicotine lozenge because the cigarette condition groups will have experienced
stronger attentional bias toward cues, and more dependence prior to the quit date and greater
withdrawal after the quit date.